Trials / Completed
CompletedNCT05236049
Use of an Allograft Set-up (SclerFIX) as Replacement of Sclera Graft for Support of Enucleation Implant
Evaluation of Safety and Efficacy of Wrapping Orbital Implant by SclerFIX Product After Eye Enucleation
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 12 (actual)
- Sponsor
- TBF Genie Tissulaire · Industry
- Sex
- All
- Age
- 45 Years – 85 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this open, monocenter pilot trial is to evaluate the tolerance of the SclerFIX product, an allograft of umbilical cord lining membrane, in the reinforcement of ocular implants in patients who underwent enucleation due to an eye malignant tumor resection.
Detailed description
As scleral graft is forbidden in France, it cannot be used for support of enucleation implants. This study investigational product, SclerFIX, was developed to substitute scleral grafts in those cases.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | SclerFIX | Chemically-treated, viro-inactivated, freeze-dried and irradiated umbilical cord lining membrane allograft used as substitute for scleral graft in support of intraocular implant. |
Timeline
- Start date
- 2019-07-01
- Primary completion
- 2022-04-27
- Completion
- 2022-04-27
- First posted
- 2022-02-11
- Last updated
- 2023-05-01
Locations
1 site across 1 country: France
Source: ClinicalTrials.gov record NCT05236049. Inclusion in this directory is not an endorsement.